Gastric Cancer ScreeningNCT07340593
Helicobacter Pylori Infection and Gastric Diseases in Lao PDR: First Community-Wide Population-Based Study
An observational study of Gastric Cancer Screening and Prevention and Control, run by Zero Helicobacter IGAN Network at 1 site in Laos.
Trial summary
This study aims to determine the regional prevalence of Helicobacter pylori infection, bacterial strain differences, and the prevalence of gastric cancer in two provinces of Laos, a multi-ethnic country where these factors may vary by region and ethnicity. The study also evaluates whether H. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer Screening, Prevention and Control, Helicobacter Eradication
- How many people
- 1,251 participants
- Where
- 1 siteLaos
- Study dates
- 18 Dec 2023to 7 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study Locations 1. Luangprabang Province, Lao PDR 2. Champasak Province, Lao PDR
Who may be able to join
- Age ≥18 years
- Resident of Luangprabang or Champasak Province
- Able to provide written informed consent
Who cannot join
- Severe comorbidities contraindicating screening or treatment
- Allergy to medications used in triple therapy
- Pregnant or breastfeeding women (if applicable)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Community-based Collaborative Study for Eradication of Helicobacter Pylori and Associated Gastric Cancer in Luangprabang and Champasak Province, in Lao PDR 2025.
This study aims to determine the regional prevalence of Helicobacter pylori infection, bacterial strain differences, and the prevalence of gastric cancer in two provinces of Laos, a multi-ethnic country where these factors may vary by region and ethnicity. The study also evaluates whether H. pylori eradication therapy contributes to disease prevention. Residents aged 18 years or older in Luang Prabang Province and Champasak Province underwent stool antigen testing, and H. pylori-positive individuals received eradication therapy. High-risk participants aged ≥40 years underwent upper gastrointestinal endoscopy for early detection of gastric cancer.
Read the detailed description
This population-based study was conducted in Laos to investigate geographic variation in Helicobacter pylori infection, bacterial strains, and the prevalence of precancerous and cancerous gastric lesions. Laos is a multi-ethnic nation, and differences in H. pylori prevalence and strain distribution are expected across ethnic groups and regions. The goal of this study is to assess the current burden of infection and evaluate the effectiveness of eradication therapy as a preventive strategy for gastric cancer.
Eligible participants were residents aged ≥18 years living in Luang Prabang Province (North) and Champasak Province (South). The study received approval from the Ethics Committee of the Ministry of Health of Laos. All participants received an explanation of the risks and benefits of screening and provided written informed consent.
The study procedures were conducted as follows:
- Stool H. pylori antigen rapid test was performed for all enrolled participants.
- Participants aged ≥40 years who tested positive were considered a high-risk group and underwent upper gastrointestinal endoscopy for early detection of precancerous gastric lesions and gastric cancer.
- All H. pylori-positive participants received 14-day triple therapy consisting of lansoprazole, amoxicillin, and clarithromycin.
- Eradication was assessed using a follow-up stool antigen test at 8 months after treatment in Luang Prabang Province and 6 months after treatment in Champasak Province.
Screening in Luang Prabang Province was conducted between December 2023 and October 2024, and screening in Champasak Province between October 2024 and June 2024.
- Conditions
- Gastric Cancer Screening, Prevention and Control, Helicobacter Eradication, Helicobacter Infections
- Keywords
- gastric cancer, helicobacter pylori, Laos, H pylori eradication, cancer prevention
- Medical subject headings
- Helicobacter Infections, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Residents of Luang Prabang Province | Residents aged ≥18 years in Luang Prabang Province who underwent stool antigen testing for H. pylori. Participants ≥40 years who tested positive additionally underwent upper endoscopy. All positive individuals received triple therapy and were followed for eradication. | |
| Residents of Champasak Province | Residents aged ≥18 years in Champasak Province who underwent stool antigen testing for H. pylori. Participants ≥40 years who tested positive additionally underwent upper endoscopy. All positive individuals received triple therapy and were followed for eradication. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of H. pylori infection • Method: Stool antigen test • Time Frame: Baseline
The proportion of participants who test positive for H. pylori infection using a stool antigen rapid test at baseline.
All enrolled residents aged ≥18 years in Luang Prabang Province and Champasak Province undergo stool antigen testing. H. pylori positivity is defined according to the manufacturer's validated cutoff value.
This measure provides a population-based estimate of the current H. pylori infection prevalence in two geographically distinct regions of Laos.
Measured: Baseline
Secondary outcomes (1)
H. pylori eradication rate after triple therapy,
The percentage of H. pylori-positive participants who achieve eradication following 14-day triple therapy, confirmed by stool antigen testing.
Measured: 6-8 months after treatment completion,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start18 Dec 2023
- Primary completion10 Oct 2024
- Study completion7 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer ScreeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,251 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zero Helicobacter IGAN Network
- Sponsor type
- University, hospital or other
- Collaborators
- Oita University, Setthathirath Hospital, Mahosot Hospital, Laos, Lao National Cancer Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07340593
- Sponsor's protocol ID
- 1015/REC
- Status last verified
- Jan 2026
- First submitted
- 19 Dec 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. Due to ethical and regulatory considerations in Laos, and because the dataset includes sensitive health information collected from community residents, de-identified participant-level data will not be made publicly available.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community-based Collaborative Study for Eradication of Helicobacter Pylori and Associated Gastric Cancer in Luangprabang and Champasak Province, in Lao PDR 2025.
- ClinicalTrials.gov ID
- NCT07340593
- Acronym / sponsor ID
- 1015/REC
- Conditions
- Gastric Cancer Screening, Prevention and Control, Helicobacter Eradication, Helicobacter Infections
- Keywords
- gastric cancer, helicobacter pylori, Laos, H pylori eradication, cancer prevention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,251 participants (actual)
- Lead sponsor
- Zero Helicobacter IGAN NetworkUniversity, hospital or other
- Collaborators
- Oita University, Setthathirath Hospital, Mahosot Hospital, Laos, Lao National Cancer Center
- Study start
- 18 Dec 2023 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 7 Jun 2025 (actual)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to determine the regional prevalence of Helicobacter pylori infection, bacterial strain differences, and the prevalence of gastric cancer in two provinces of Laos, a multi-ethnic country where these factors may vary by region and ethnicity. The study also evaluates whether H. pylori eradication therapy contributes to disease prevention. Residents aged 18 years or older in Luang Prabang Province and Champasak Province underwent stool antigen testing, and H. pylori-positive individuals received eradication therapy. High-risk participants aged ≥40 years underwent upper gastrointestinal endoscopy for early detection of gastric cancer.
Detailed description
This population-based study was conducted in Laos to investigate geographic variation in Helicobacter pylori infection, bacterial strains, and the prevalence of precancerous and cancerous gastric lesions. Laos is a multi-ethnic nation, and differences in H. pylori prevalence and strain distribution are expected across ethnic groups and regions. The goal of this study is to assess the current burden of infection and evaluate the effectiveness of eradication therapy as a preventive strategy for gastric cancer.
Eligible participants were residents aged ≥18 years living in Luang Prabang Province (North) and Champasak Province (South). The study received approval from the Ethics Committee of the Ministry of Health of Laos. All participants received an explanation of the risks and benefits of screening and provided written informed consent.
The study procedures were conducted as follows:
- Stool H. pylori antigen rapid test was performed for all enrolled participants.
- Participants aged ≥40 years who tested positive were considered a high-risk group and underwent upper gastrointestinal endoscopy for early detection of precancerous gastric lesions and gastric cancer.
- All H. pylori-positive participants received 14-day triple therapy consisting of lansoprazole, amoxicillin, and clarithromycin.
- Eradication was assessed using a follow-up stool antigen test at 8 months after treatment in Luang Prabang Province and 6 months after treatment in Champasak Province.
Screening in Luang Prabang Province was conducted between December 2023 and October 2024, and screening in Champasak Province between October 2024 and June 2024.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Residents of Luang Prabang Province | – | –Residents aged ≥18 years in Luang Prabang Province who underwent stool antigen testing for H. pylori. Participants ≥40 years who tested positive additionally underwent upper endoscopy. All positive individuals received triple therapy and were followed for eradication. |
| Residents of Champasak Province | – | –Residents aged ≥18 years in Champasak Province who underwent stool antigen testing for H. pylori. Participants ≥40 years who tested positive additionally underwent upper endoscopy. All positive individuals received triple therapy and were followed for eradication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study Locations 1. Luangprabang Province, Lao PDR 2. Champasak Province, Lao PDR
Key inclusion criteria (3 listed)
- Age ≥18 years
- Resident of Luangprabang or Champasak Province
- Able to provide written informed consent
Key exclusion criteria (3 listed)
- Severe comorbidities contraindicating screening or treatment
- Allergy to medications used in triple therapy
- Pregnant or breastfeeding women (if applicable)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of H. pylori infection • Method: Stool antigen test • Time Frame: Baseline
Time frame: Baseline
The proportion of participants who test positive for H. pylori infection using a stool antigen rapid test at baseline. All enrolled residents aged ≥18 years in Luang Prabang Province and Champasak Province undergo stool antigen testing. H. pylori positivity is defined according to the manufacturer's validated cutoff value. This measure provides a population-based estimate of the current H. pylori infection prevalence in two geographically distinct regions of Laos.
1 secondary outcome
H. pylori eradication rate after triple therapy,
Time frame: 6-8 months after treatment completion,
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. Due to ethical and regulatory considerations in Laos, and because the dataset includes sensitive health information collected from community residents, de-identified participant-level data will not be made publicly available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer Screening and Prevention and Control, run by Zero Helicobacter IGAN Network at 1 site in Laos.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Laos. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of H. pylori infection • Method: Stool antigen test • Time Frame: Baseline (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.